By Sylvia Hsieh
The Daily Record Newswire
BOSTON, MA — Litigation over the drug Actos is gaining momentum as a mass tort.
Lawyers around the country have begun filing lawsuits and investigating additional claims that the drug, prescribed to improve blood sugar in type II diabetics, causes bladder cancer.
They anticipate at least several thousand lawsuits.
“We think this is fairly large litigation,” said Hunter J. Shkolnik, a partner with Napoli Bern Ripka & Skolnik in New York, N.Y., who filed one of the first suits in California.
“We anticipate 5,000 to 15,000 cases out there, although there could be many more than that depending on so many factors, such as dose and duration,” said
Chris Paulos, an attorney with Levin Papantonio Thomas Mitchell Rafferty & Proctor in Pensacola, Fla., who recently spoke at a teleseminar on this topic.
In June, the FDA issued a safety announcement that taking Actos for more than a year is associated with an increased risk of bladder cancer, and recommended
that doctors not use Actos in patients with active bladder cancer and exercise caution in using Actos in patients with a history of bladder cancer.
The FDA said it continues to review data from an ongoing ten-year study and the results of a French study showing an increased risk of bladder cancer.
In light of the French study, France barred Actos from its market and Germany recommended halting its use in new patients.
Leading diabetes drug
Actos, or pioglitazone, was approved in 1999 by the FDA as a class of drugs known as thaizolidinediones (TZDs) to control blood sugar in type II diabetics.
The drug was jointly launched by Takeda North America and Eli Lilly and Company, both named as defendants in the lawsuits.
Actos became a leading prescription drug for type II diabetes after doctors stopped prescribing Rezulin and Avandia because of cardiac problems associated with those drugs.
According to plaintiffs’ attorneys, most studies were focused on heart problems while bladder cancer results from the same studies fell under the radar.
“During the course of looking at the drug for heart risk, they uncovered bladder cancer risk [but] that does not get followed up on,” said Shkolnik.
The lawsuits cite to a study before the drug was approved showing increased urinary bladder tumors in male rats, and a 2005 study called PROactive sponsored by Actos’ manufacturer Takeda in collaboration with marketer Eli Lilly.
The PROactive study, said Dawn Chmielewski, an attorney with Climaco, Wilcox, Peca, Tarantino & Garofoli in Cleveland, “was looking at cardiovascular events and outcomes. However, the study demonstrated a higher percentage of bladder cancer cases in patients who received Actos versus comparators.”
Those results were not published, according to an Aug. 23 complaint Chmielewski filed on behalf of a Lorain, Ohio man who developed bladder cancer after taking Actos for nearly two years.
An ongoing ten-year study by Kaiser Permanente is also looking at an association between Actos and bladder cancer. Plaintiffs’ attorneys point to a five-year interim analysis of that study showing the risk of bladder cancer increases the longer and higher the dosage of Actos.
“In a shocking spin on words … vice president of medical and scientific affairs for Tekeda claimed … that the study has not shown a risk to patients of bladder cancer from Actos,” Shkolnik claims in a lawsuit filed Aug. 1 that alleges several counts, including fraud, and seeks punitive damages.
Representatives of Takeda did not return a call seeking comment for this article.
Kelley Murphy, Eli Lilly’s director of communications for Lilly Diabetes, said the company does not comment on litigation matters but that “Lilly Diabetes is dedicated to patient safety and to ensuring that patients and physicians have accurate information regarding pioglitazone.” She also noted that in 2006, Takeda took over all marketing and sales responsibilities for pioglitazone in the U.S.
‘What did they know, when did they know it?’
Plaintiffs’ lawyers allege that the defendants failed to warn about the risks of bladder cancer, despite what they knew from the studies.
“The big issue is: What did they know and when did they know about it? When did they start seeing a spike [in bladder cancer]? To whom and when did they report it? Did they update their label and marketing when it had the information?” said Shkolnik.
Chmielewski expects defendants to dispute the studies’ findings.
“Based on comments the company made after the FDA warning and French study, they do not agree with the numbers as statistically significant,” she said.
In deciding which cases they are going to take, plaintiffs’ attorneys are weighing the individual profiles of potential plaintiffs against likely challenges to specific
causation.
“Bladder cancer is the fourth most common cancer for males. Of course the defendants are going to point to every other cause of bladder cancer,” said Paulos.
For example, some lawyers are shying away from Actos cases for plaintiffs who are smokers, while others say that the studies have accounted for smoking in their calculation of the increased risk of bladder cancer.
Combing through potential plaintiffs, lawyers have assessed the best possible cases as those farthest from the statistical profile of bladder cancer victims.
“The poster child plaintiff would be a young African American woman who doesn’t have occupational exposure to fumes or metals, who’s never smoked and who’s never had a personal history or family history of cancer,” said Paulos, adding that those who took Actos in higher doses or for longer periods of time are at greater risk, and therefore stronger plaintiffs.
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